New Accreditation Routes to Expedite Access to Medicines in the UK


The new accreditation route will facilitate faster and safer access to innovative medicines through seven international partners, according to the UK’s MHRA.

New Accreditation Routes to Expedite Access to Medicines in the UK

The Medicines and Healthcare Products Regulatory Agency (MHRA) has announced that it will establish a new international regulatory approval route for medicines, using approvals from the EU, Switzerland, the US, Canada, Australia, Singapore and Japan.

According to the MHRA, this approval route marks the beginning of a new international approval framework for medicines to be introduced by the first quarter of 2024.

The new framework will allow UK medicines regulators to streamline the evaluation of certain products, allowing cutting-edge medicines approved in other countries to reach UK patients more quickly, reducing costs for the industry. Connect.

New UK point-of-care manufacturing regulatory framework

Introduction of a new international regulatory approval route

The new route will parallel the MHRA’s Pharmaceutical Innovation pathway, which integrates early regulatory advice and health technology assessment advice.

When the UK leaves the EU in 2020, the MHRA introduced a temporary supply chain route to bring European approved products to market in the UK. These are known as the EU’s ‘routes of trust’ to ensure that patients continue to have timely access to new treatments. The MHRA said these temporary routes are due to expire at the end of 2023.

MHRA Chief Executive Dr. June Lane said, “The introduction of the new route complements the work being done through MHRA’s Innovative License Access Pathway (ILAP) to accelerate access to life-saving new medicines. It will establish additional avenues for

Through ILAP, Boehringer Ingelheim’s investigational drug BI 907828 in dedifferentiated liposarcoma (DDLPS) was awarded an MHRA Innovation Passport in November 2022. It is a rare tumor cancer for which there has been no new first-line treatment for over 40 years. Read more about Boehringer Ingelheim’s ILAP designation here.

In March 2023, the UK Treasury announced a total contribution of £10m to the MHRA to support the development of a new recognition framework. This will help bring innovative new medicines, such as cancer vaccines and AI-based treatments for mental illness, to UK patients more quickly.

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